Method and system for prion inactivation
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[0052]The efficacy tests were conducted by placing a CSR-wrapped tray (3.5″×10″×20″) consisting of representative medical devices and test lumens in a 20-liter aluminum chamber (4.4″×12″×22″). A one-inch stainless steel wire inoculated with at least 1×106 Bacillus stearothermophilus spores was placed in the center of each of the test lumens. The effects with and without temperature control of the diffusion path were investigated with both a TEFLON, poly(tetrafluoroethylene)lumen having an internal diameter of 1 mm and a length of 700 mm, and a stainless steel lumen having an internal diameter of 1 mm, and a length of 500 mm. All lumens were open at both ends. Each of the samples were subjected to a sterilization cycle in a 20 liter vacuum chamber, which was held at 40° C. and 3 torr for 5 minutes. 1.44 ml of a 59% solution of hydrogen peroxide in water was injected at atmospheric pressure into the vaporizer which was held at 60° C. The 5 minute clock then started and the chamber was...
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